A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes

Not Applicable

Completed

Conditions: Gestational Diabetes

Registration Number: NCT04803357

Lead Sponsor: University of Washington

Brief Summary: The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population.

Detailed Description: Pregnant Participants diagnosed with gestational diabetes are being invited to take part in a research study because these participants are pregnant and have gestational diabetes. Participants will be offered an opportunity to wear a medical device that monitors blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in the abdomen by a skin prick. Typically, participants cannot feel this device once it is inserted. If participants agree to participate in this study, participants will be randomly placed into one of two groups: (1) the intervention group or (2) the control group. Participants will have a 50% (1 out of 2) chance like a coin toss of being placed into either group. If participants are in the intervention group, they will wear a real-time continuous glucose monitoring device (RT-CGM). The RT-CGM will allow participants to see glucose levels in real time. The RT-CGM will send information about glucose levels to a phone or display device so participants may see the glucose at all times. If participants are in the control group, they will not be given a RT-CGM. Instead, participants will be given a blinded CGM device. You will not be able to view your blood sugar results on the blinded CGM device. If participants are in the control group, they will also be given a blood glucose meter to check glucose using finger sticks according to the recommendations of the provider.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 105

Inclusion Criteria

Pregnancy and Gestation < 30 weeks
Singleton pregnancy
Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
Able to read English and completed 6th grade
Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements

Exclusion Criteria

Pre-gestational Type 1 or Type 2 diabetes.
Newly diagnosed overt-diabetes in pregnancy [HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l].
Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
Known endogenous/exogenous Cushing's syndrome
Known chronic infections
Current use of any oral form of steroid medication
Already receiving continuous glucose monitoring (CGM)
History of bariatric surgery
Gestational Age less than 14 weeks -

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean Glucose	36 weeks	mean glucose CGM
TIR CGM	36 weeks	Time in range, 63 - 140 mg/dL (TIR) by % continuous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Shoulder Dystocia	delivery	number with shoulder dystocia at delivery
A1c	36 weeks	A1c at 36 weeks
Fructosamine	36 weeks	frucosamine at 36 weeks
Short Food Questionnaire	36 weeks	starting the conversation food questionnaire Possible scores range from 0 to 16 with lower scores indicating better nutrition including more fruits and vegtables, and less or no sugared beverages.. The most healthful answer for each question is scored 0. The less healthful answer is scored 1. The least healthful answer is scored 2. To get a total score, add up the individual item scores. The total score ranges from 0 to 16. Lower scores indicate better nutrition
WHO QOL Scale	36 weeks	World health organization Quality of Life survey Possible scores range from 0 to 25 with higher scores indicating more happiness or contentment.
Diabetes Distress(PAID) Survey	36 weeks	5 items diabetes distress score Possible total score ranges from 0 to 20. Higher scores indicate more emotional distress.
Walking Time Physcial Active Questionnaire	36 weeks	% of participants walking greater than 10 minutes or more per day
Metformin Only Use	at 36 weeks	use of metformin only
Insulin Use Only	at delivery	use of insulin only
Diabetes Medication Use Delivery	at delivery	use of metformin and insulin in pregnancy
Metformin Use Only at Delivery	at delivery	use of metformin only at time of delivery
Fetal Birthweight	delivery	Birth weight \[grams; mean (SD)\]
TBR CGM GDM	36 weeks	Time below range, 63 mg/dL threshold (TBR63) GDM
TAB CGM GDM	36 weeks	Time above range, 140 mg/dL threshold (TAR140)
MAGE CGM	36 weeks	Mean Amplitude of glycemic excursions (MAGE) continuous glucoe monitoring
SD CGM	36 weeks	standard deviation Continuous glucose monitoring
CV CGM	36 weeks	Coefficient of variation, % (CV)The Coefficient of Variation (%CV) is calculated by dividing the glucose Standard Deviation by the mean glucose. The %CV is a standardized measure that assesses the magnitude of glucose variability. The larger the %CV, the larger the variability in CGM readings.
Neonatal Hypoglycemia	delivery	number(%) \<40mg/dl of neonatal hypoglycemia
Gestational Age at Delivery	delivery	gestational age at delivery weeks mean (sd)
Mode of Delivery	delivery	mode of deliver reported ( vaginal, c-section, operative vaginal)
Type of Labor	delivery	Labor Status on Admission -(induced, spontaneous, planned c-section
Preeclampsia or HTN	delivery	Preeclampsia or Gestational hypertension (HTN )
Maternal Weight Gain	delivery	Maternal weight gain \[lbs; mean (SD)\] at delivery
Diabetes Medication Use	at 36 weeks	use of metformin and insulin in pregnancy
5 Minute Apgar	delivery	5 minute apgar score A 5-minute Apgar score is a quick assessment of a newborn's overall health, particularly their ability to transition to life outside the womb. It's a score between 0 and 10, with each component (appearance, pulse, grimace, activity, and respirations) receiving a score of 0, 1, or 2. A score of 7-10 is considered reassuring, while scores below 7 may indicate the need for medical attentio
Live Birth or Stillbirth	devlivery	live birth or still birth at delivery
Birthweight Ratio	delivery	Birthweight ratio Birth weight ratio is defined as the ratio of observed birth weight divided by the median birth weight of the population-specific reference growth curve (based on 50% weight for gestational age). It is used to compare the birth weight of a fetus to the median for its gestational age. Higher birth weight ratios indicate larger fetuses for their gestational age, while lower ratios indicate smaller fetuse.
NICU Admission	delivery	Need for neonatal intensive care admission
Neonatal Complications	delivery	neonatal respiratory distress, birth injury, hypoxic encephalopathy
Glucose Meter Fingerstick Per Day	36 weeks	mean number of fingersticks per day by 36 weeks
Mean Days of RT-CGM Use	36 weeks	Mean (SD) days of RT-CGM use